Flexible support for gel wraps

ABSTRACT

A two-ply bandage for treatment of skin while providing orthopedic support having a first layer of gel for contacting the skin and a second layer of an elastic and supportive loop portion of a hook and loop fastener. The product is economically manufactured in the form of long rolls or as a sheet and is easily cut to any desired shape.

[0001] This application claims the benefit of U.S. ProvisionalApplication 60/226,602, filed Aug. 21, 2000.

BACKGROUND OF THE INVENTION

[0002] The present invention relates to a medical or surgical bandagesuitable for use in providing musculo-skeletal support and treatment ofskin conditions. In particular, the invention relates to positioning agel against the skin utilizing a stretchable bandage that also providesthe added benefit of orthopedic, or musculo-skeletal, support for thejoint or portion of the body on which the bandage is wrapped.

[0003] More specifically, this invention relates to a composite materialconsisting of two layers; a layer of gel bonded to a stretchable carrierlayer of a rigid and elastic loop portion of a hook and loop fastener.The stretch carrier layer is useful for positioning the gel layer inplace on the body while at the same time providing substantialmusculo-skeletal support to the portion of the body around which thebandage is wrapped.

SUMMARY OF THE INVENTION

[0004] This invention relates to a composite structure whichincorporates the pressure therapy features of a rigid yet stretchablecarrier material with a silicone gel for treatment of skin conditions.Silicone gel materials are used in the medical field for the managementof such conditions, for example, as dermal scarring, varicose veins andstasis ulcers. These silicone materials soften scar tissue and improvethe cosmetic as well as functional aspects of scars for instance.

[0005] There is a need in the medical and veterinary fields to combinesupportive (pressure) therapy with a gel treatment, particularly on theextremities of the body. In the case of veterinary applications, fur isused herein interchangeably with skin. Supportive pressure therapy isuseful, for example, to provide musculo-skeletal support for joints andmuscles, and in the treatment of carpal tunnel syndrome, arthritis andtennis elbow. This is not easy or convenient under present methods.Typically in the medical and veterinary fields supportive pressuretherapy is provided using compression garments or wraps. When used witha gel, a person must typically apply a layer of gel to the area of thebody to be treated followed by wrapping another material such as acompression garment or wrap to keep the gel in position. The materialstypically used don't provide the elastic support usually desired andtherefore require many wraps of the material. Furthermore, typicalmaterials lose much of their elasticity after only a couple of uses.

[0006] Hook and loop fasteners are now available with rigid yetstretchable loop portions that have a modulus of elasticity of about50%, with no stretch memory. The strong elastic property provided by thestretchable loop portion makes it possible for a bandage using thismaterial to be wrapped only once around a part of the body whilemaintaining contact with the skin to be treated. By applying a surfacelayer of silicone gel to the flat side (non-loop surface) of astretchable loop portion of a hook and loop fastener, it was discoveredthat bandages can be produced which provide a surface layer of siliconefor uniform skin contact with the added benefit of musculo-skeletalsupport. The bandage of this invention having a stretchable loop portionas the carrier layer for the gel can therefore follow the many shapesand anatomical contours of the body while at the same time providingsecure positioning of the gel on the skin of the user. The combinationof stretch carrier and gel layer provides greater comfort to the userbecause the bandage allows for movement and flexing of the body withoutreduction in the bandages effectiveness, i.e. support and resistance toslipping. Thus, the support provided by this invention offers the wearerof the bandage greater comfort and durability and makes for the idealbandage for repeated usage and/or usage over long periods of time.

[0007] This invention is an improvement over the prior art in that (a)the carrier material is rigid and elastic so that substantial orthopedicsupport (i.e., musculo-skeletal support) is provided by just a one layerwrapping, (b) the product is far more durable than Lycra® and otherknown, thin elastic based products commonly available, (c) both pressureand silicone therapies may be applied concomitantly by this inventionand therefore eliminating a separate and/or repeated process of fittingmore than one material individually, and (d) patient compliance may beimproved because continued, even long term, comfortable use of theproduct is possible without loss of support from the carrier material.Furthermore, the carrier of the present invention provides the addedbenefit of a bandage that supplies even pressure to the body across thearea of the bandage being treated.

[0008] The manufacturing process of this invention lends itself tolarge-scale production in either flat sheets or long rolls. Final shapesof limitless configurations can then easily be cut from the sheets orrolls. This provides for rapid and cost effective production ofcustom-made shapes for any given application or patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 is a perspective view illustrating the use of oneembodiment of this invention on the knee of a user.

[0010]FIG. 2 is an embodiment illustrating gel layer 5 bonded tocarrier10 having loop surface 15.

[0011]FIG. 3 illustrates carrier10, having a loop surface 15, bonded togel layer 5.

[0012]FIG. 4 illustrates closure strip 20

[0013]FIG. 5 illustrates a method of manufacture using gel bath 30 andcarrier10

[0014]FIG. 6 illustrates river of carrier 10 and uncured gel compound40.

[0015]FIG. 7 is a perspective view illustrating the use of particularembodiments of this invention adjacent to the knee joint of a user.

[0016]FIG. 8 is a perspective view illustrating the use of an embodimentof the present invention about the thigh of a user, and showing loopsurface 15 of the bandage and closure strips 20.

DETAILED DESCRIPTION OF THE INVENTION

[0017] The description provided below references FIGS. 1 through 8 aspart of the disclosure and the associated reference numerals.

[0018] The device of the present invention, shown in FIGS. 1 through 3,7 and 8, is generally described as a rigid yet stretchable bandage witha silicone gel coating 5 on one side. The carrier 10 is a thick,stretchable loop portion of a hook-and-loop fastener such as Velcro®. Ina particular embodiment, carrier 10 is about ⅛ inch thick. The siliconegel used in gel 5 is commercially available as either a 1:1, 3:1, or10:1 mixture of a polydiorganosiloxane resin and a catalyst. Generallyspeaking, the silicone gel is an addition cured polydimethyl-siloxanegel. This type of gel is well described in the literature, includingsome of the existing patent literature (e.g. U.S. Pat. No. 4,991,574(“Pocknell”) which is incorporated herein by reference). There is noparticular reason to limit our device to silicone gel, if there areother gels that provide clinical benefit. Further, additives may beintroduced into the gel, including, for example, oils, Ben-Gay™, andother topical medications and emoluments that seep into the skin area onwhich the gel is applied. Although other gels may be used, silicone gelhas the special benefit of reducing the appearance of hypertrophic andkeloid scarring. The advantages of silicone gel are widely known and arealso well described in the existing patent literature (e.g. U.S. Pat.Nos. 5,759,560 (“Dilon”), 5,656,279 (“Dillon”), and 5,895,656(“Hirschowitz et al.”) all the contents of which are herein incorporatedby reference. Silicone gel is also known to be hydrophobic, so it won'tbreak down or change characteristics in the presence of water or sweat.Cured silicone gel is cohesive (retains its shape) but is not verystrong. It can be easily torn, and to be handled by the average person,it must be reinforced with some alternate carrier material.

[0019] In the present invention, carrier 10 is preferably a commerciallyavailable loop portion of a stretchable hook-and-loop and-loop fastenersuch as, for example Velstretch®. This “stretch” carrier is essentiallythe traditional loop portion of a hook-and-loop fastener woven with anelastic material. Depending on the degree of “stretch” needed, differentelastic interweaves may be used, and from which a stretch ofapproximately 50% in one direction may be obtained. This carrier, orsubstrate, provides the backbone, or compressive force, necessary toapply the silicone gel to any contour on the body, especially joints,both large and small, while also providing the benefit of support to theunderlying tissue. The thickness of the carrier also provides support tothe joint, so that the pain and discomfort of joint inflammation due toa variety of medical conditions is minimized. An added benefit of thecarrier is to provide protection, for example, from abrasion, to thesurface of the skin upon which the invention is applied. The support andprotective aspects of the present invention, as described above, easilylend themselves to uses on animals as well.

[0020] In a particularly preferred embodiment, the “fuzzy” side or“loop” side 15 of the carrier 10 is used as the carrier for the gel. Thebandage may be secured about the afflicted joint or area of the bodywith a complimentary strip of the hook portion 20 (FIG. 4) of a hook andloop fastener material which may be used to keep the bandage closedaround the joint or area of the body. Multiple strips or one large stripof width equal to approximately the width of the bandage may also beused to provide proper securing of the bandage as shown in FIG. 7.

[0021] In one particularly preferred embodiment, the combined product ofthis invention has the “loop” side, or loop portion 15 (the soft side),of the stretch carrier 10 on one side and a layer of silicone gel on theother. The gel goes against the skin, and the product is fixed in placeby wrapping the body portion with the bandage and applying acomplimentary “hook” or closure strip 20 of fastener material at anypoint along the bandage seam.

[0022] An embodiment of this invention could be provided in a roll form,about 3″ wide by about 1 foot long for applications such as thosecurrently employing use of an Ace® type bandage. In this configuration,the present invention can replace the application of Ace-type bandagesfor musculo-skeletal support and other orthopedic bandages which arespecially configured to fit knees, ankles, wrists, elbows, and otherproblematic joints. Other dimensions applicable to specific applicationsare also contemplated, such as for use around a thigh or forearm.

[0023] It is an embodiment of the present invention for the stretchablecarrier 10 to provide a platform for the gel to be continuously appliedagainst any existing scar, which will in turn provide the widelyunderstood benefit of reduced scar appearance. Because the gel isdeposited on the carrier 10 while the carrier 10 is in the un-stretchedposition, it should be understood that, as the carrier 10 is expanded,the gel also expands in the same direction. This will allow air tocirculate into the treated area, reducing discomfort due to sweating,yet still provide the benefit of the gel applied against the scar.Further, as the carrier 10 is expanded and then closed using the hooksection, the carrier 10 provides compression and support to the affectedarea.

[0024] The silicone gel provides an additional comfort factor of“coolness” against the skin, which is not diminished to any large degreeby keeping the present invention in place for the required period.Because the present invention is comfortable, supportive, adaptable,stretchable, trimmable, usable on any joint or area of the body aroundwhich it can be wrapped, it is expected to result in higher patientcompliance with the treatment.

[0025] A method of manufacturing the present invention is shown in FIG.5, and described as follows.

[0026] The desired gel is mixed as designated by the materialmanufacturer, i.e. 1:1, 3:1, or 10:1 parts resin and catalyst, althoughthe mixture can be varied to obtain different degrees of tack from thefinal cured gel. The mixture is poured onto a flat surface, such aslarge sheet of polycarbonate, and allowed to settle until it is aconsistent thickness. The gel, after having been allowed to settle, hasa consistent thickness and is surrounded by an appropriate sized wall tocontain the gel on the polycarbonate surface. In one embodiment, the gelthickness is approximately 2 mm, although the thickness may vary from aslittle as 0.5 mm up to 4 mm. Meanwhile, the carrier 10 may be washed ina mild soapy solution such as Ivory® soap to remove the oils and agentsused in processing the fabric, and allowed to air dry. After the gel issettled to a consistent thickness (about 20-60 minutes) the dry carrier10 is placed on top with the loop surface of the carrier 10 away fromthe gel. The assembled materials are then allowed to cure. In apreferred embodiment, the combined gel and carrier 10 are placed in anoven for 1-3 hours and at a temperature of about 100 to 180 degreescentigrade until the gel is cured. The cured, assembled materials arethen removed from the oven and can then be cut into any shape desired.

[0027] The present invention also lends itself well to mass productionby coextrusion as shown in FIG. 5. In this embodiment, stretchablecarrier 10 is continuously unrolled from a large roll of material onto abath 30 of gel. As the carrier 10 is removed from the bath 30 a layer ofgel 40 adheres to the carrier 10 and settles to a uniform thickness. Thestream of combined carrier/gel is then passed through a heating oven andcured. At the other end of the oven are take-up rolls and/or cuttingfixtures to facilitate rolling or cutting the cured product into anydesired configuration.

[0028] In another embodiment shown in FIG. 6, an amount of gel 40 isdeposited onto a river of carrier 10 as the carrier 10 passes beneaththe gel. A layer of gel is formed on the side of the carrier 10 oppositethe loops and the gel is allowed to settle to a uniform thickness. Theriver of combined carrier/gel material is then passed through a heatingoven and cured. At the other end of the oven are take-up rolls and/orcutting fixtures to facilitate rolling or cutting the cured product intoany desired configuration.

[0029] Using either of the previous embodiments, there are specificproduction techniques which will result in a consistent layer of gelbeing applied to the flat side of the stretch carrier 10, opposite theloop side.

1. A stretchable, supportive bandage comprising: a gel layer having askin contacting surface and an adhesion surface opposite said the skincontacting surface; and a stretchable carrier layer having an outersurface and an adhesion surface[[,]] bonded to the adhesion surface ofthe gel layer to form the stretchable, supportive bandage.
 2. Thebandage of claim 1, wherein said gel is a silicone gel.
 3. The bandageof claim 1, wherein the carrier has an elastic modulus of about 50%. 4.The bandage of claim 1, wherein the stretchable carrier is a stretchableloop portion of a hook and loop fastener, with the loop portion having aloop surface and an opposite surface, wherein the opposite surface isthe adhesion surface.
 5. The bandage of claim 4, further comprising aclosure strip which is the hook portion of a hook and loop fastener,whereby the bandage is removably secured around a part of the body[[,]]6-27. (canceled)
 28. The bandage of claim 1, wherein the gel layercontains an additive.
 29. The bandage of claim 1, which is in the formof a sheet or a roll.
 30. The bandage of claim 1, wherein the gel is asilicone gel; wherein the stretchable carrier is a stretchable loopportion of a hook and loop fastener; having a loop surface and a flatadhesion surface.
 31. The bandage of claim 30, wherein the silicone gelis a cured polydiorganosiloxane resin.
 32. The bandage of claim 30,wherein the silicone gel contains an additive which is a topicalmedication or an emolient.
 33. The bandage of claim 30, wherein thestretchable carrier has an elastic modulus of about 50%.
 34. The bandageof claim 30, which is in the form of a sheet or a roll.
 35. The bandageof claim 30, further comprising a closure strip for securing the bandagearound a part of the body, which strip is the hook portion of a hook andloop fastener.
 36. The bandage of claim 35, wherein the bandage issecured around the body part with the closure strip, whereby the securedbandage provides musculo-skeletal support to the bandaged body part. 37.The bandage of claim 36, wherein the body part is a joint or a muscle.38. The bandage of claim 37, wherein the joint is a knee, an ankle, awrist, or an elbow.
 39. The bandage of claim 30, for use in a veterinaryapplication.